Lcr35 for Children With Functional Constipation

Medical University of Warsaw

Status: Completed

Conditions: Constipation

Treatments: Dietary Supplement: Lactobacillus casei rhamnosus Lcr35; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01985867

1-2013

Details and patient eligibility

About

The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.

Full description

Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.

Enrollment: 94 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children below 5 years of age

• Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:

  • Two or fewer defecations per week
  • At least 1 episode per week of incontinence after the acquisition of toileting skills
  • History of excessive stool retention
  • History of painful or hard bowel movements
  • Presence of a large fecal mass in the rectum
  • History of large- diameter stools that may obstruct the toilet

Exclusion criteria

• Irritable bowel syndrome
• Mental retardation
• Endocrine disease (e.g. hypothyroidism)
• Organic cause of constipation (e.g. Hirschsprung disease)
• Spinal anomalies
• Anatomic defects of the anorectum
• History of previous gastrointestinal surgery
• Functional nonretentive fecal incontinence
• Use of drugs that influence gastrointestinal motility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

Lactobacillus casei rhamnosus Lcr35

Experimental group

Description:

Eligible children will receive Lactobacillus casei rhamnosus Lcr35 8×10\^8 colony forming units (CFU), twice daily, orally for 4 weeks

Treatment:

Dietary Supplement: Lactobacillus casei rhamnosus Lcr35

Placebo

Placebo Comparator group

Description:

Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks

Treatment:

Dietary Supplement: Placebo